Virata recallZ-0478-2026 · Orthofix U.S. LLC · initiated Sep 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Orthofix U.S. LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Polyaxial screws do not meet performance standards.
FDA root cause category: Process change control
What the company is doing
Orthofix notified consignees via email on 09/19/2025. Consignees were instructed to immediately discontinue use of the affected devices, quarantine all affected inventory, and return units to Orthofix using the provided Return Goods Authorization (RGA) process. Surgeons were instructed to monitor affected patients according to standard clinical practice. Customers were advised not to implant or distribute any remaining affected product. All consignees were requested to complete and return the response form.
Recall details
- Recall number
- Z-0478-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 19, 2025
- Posted by the FDA
- Nov 7, 2025
- Recalling firm
- Orthofix U.S. LLC
- Quantity
- 624 units
- Product code
- NKB
- FDA submissions
- K250908
- Distribution
- US Nationwide distribution in the states of California, North Carolina, and Texas.
Product description
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following sizes are affected: 1. POLYAXIAL SCREW, CC, 5.5mm X 30mm; Item Number: TL1-10755030. 2. POLYAXIAL SCREW, CC, 5.5mm X 35mm; Item Number: TL1-10755035. 3. POLYAXIAL SCREW, CC, 5.5mm X 40mm; Item Number: TL1-10755040. 4. POLYAXIAL SCREW, CC, 5.5mm X 45mm; Item Number: TL1-10755045. 5. POLYAXIAL SCREW, CC, 5.5mm X 50mm; Item Number: TL1-10755050. 6. POLYAXIAL SCREW, CC, 6.5mm X 30mm; Item Number: TL1-10765030. 7. POLYAXIAL SCREW, CC, 6.5mm X 35mm; Item Number: TL1-10765035. 8. POLYAXIAL SCREW, CC, 6.5mm X 40mm; Item Number: TL1-10765040. 9. POLYAXIAL SCREW, CC, 6.5mm X 45mm; Item Number: TL1-10765045. 10. POLYAXIAL SCREW, CC, 6.5mm X 50mm; Item Number: TL1-10765050. 11. POLYAXIAL SCREW, CC, 6.5mm X 55mm; Item Number: TL1-10765055. 12. POLYAXIAL SCREW, CC, 6.5mm X 60mm; Item Number: TL1-10765060. 13. POLYAXIAL SCREW, CC, 7.5mm X 30mm; Item Number: TL1-10775030. 14. POLYAXIAL SCREW, CC, 7.5mm X 35mm; Item Number: TL1-10775035. 15. POLYAXIAL SCREW, CC, 7.5mm X 40mm; Item Number: TL1-10775040. 16. POLYAXIAL SCREW, CC, 7.5mm X 45mm; Item Number: TL1-10775045. 17. POLYAXIAL SCREW, CC, 7.5mm X 50mm; Item Number: TL1-10775050. 18. POLYAXIAL SCREW, CC, 7.5mm X 55mm; Item Number: TL1-10775055. 19. POLYAXIAL SCREW, CC, 7.5mm X 60mm; Item Number: TL1-10775060. 20. POLYAXIAL SCREW, CC, 8.5mm X 35mm; Item Number: TL1-10785035. 21. POLYAXIAL SCREW, CC, 8.5mm X 40mm; Item Number: TL1-10785040. 22. POLYAXIAL SCREW, CC, 8.5mm X 45mm; Item Number: TL1-10785045. 23. POLYAXIAL SCREW, CC, 8.5mm X 50mm; Item Number: TL1-10785050. 24. POLYAXIAL SCREW, CC, 8.5mm X 55mm; Item Number: TL1-10785055. 25. POLYAXIAL SCREW, CC, 8.5mm X 60mm; Item Number: TL1-10785060.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
1. Item Number: TL1-10755030. UDI-DI: 10889981335229. Lot Number: JP2572B. 2. Item Number: TL1-10755035. UDI-DI: 10889981336165. Lot Number: JP2757B. 3. Item Number: TL1-10755040. UDI-DI: 10889981335717. Lot Number: JP2758B. 4. Item Number: TL1-10755045. UDI-DI: 10889981335953. Lot Numbers: JP2759B, JP2799B, JP2800B, JP2880B. 5. Item Number: TL1-10755050. UDI-DI: 10889981336318. Lot Numbers: JP2760B, JP2801B. 6. Item Number: TL1-10765030. UDI-DI: 10889981335885. Lot Number: JP2655B. 7. Item Number: TL1-10765035. UDI-DI: 10889981335540. Lot Number: JP2656B. 8. Item Number: TL1-10765040. UDI-DI: 10889981336332. Lot Number: JP2657B, JP2791B. 9. Item Number: TL1-10765045. UDI-DI: 10889981335526. Lot Numbers: JP2658B, JP2659B, JP2792B. 10. Item Number: TL1-10765050. UDI-DI: 10889981335342. Lot Numbers: JP2660B, JP2794B, JP2795B. 11. Item Number: TL1-10765055. UDI-DI: 10889981335168. Lot Number: JP2661B. 12. Item Number: . UDI-DI: . Lot Number: Item Number: TL1-10765060. UDI-DI: 10889981335816. Lot Number: JP2662B. 13. Item Number: TL1-10775030. UDI-DI: 10889981335427. Lot Number: JP2663B. 14. Item Number: TL1-10775035. UDI-DI: 10889981335632. Lot Number: JP2668B. 15. Item Number: TL1-10775040. UDI-DI: 10889981335113. Lot Number: JP2669B. 16. Item Number: TL1-10775045. UDI-DI: 10889981335403. Lot Number: JP2670B. 17. Item Number: TL1-10775050. UDI-DI: 10889981335830. Lot Number: JP2671B. 18. Item Number: TL1-10775055. UDI-DI: 10889981335250. Lot Numbers: JP2672B, JP2887B. 19. Item Number: TL1-10775060. UDI-DI: 10889981335076. Lot Number: JP2673B. 20. Item Number: TL1-10785035. UDI-DI: 10889981335410. Lot Number: JP2674B. 21. Item Number: TL1-10785040. UDI-DI: 10889981335779. Lot Number: JP2675B. 22. Item Number: TL1-10785045. UDI-DI: 10889981335243. Lot Number: JP2664B. 23. Item Number: TL1-10785050. UDI-DI: 10889981335847. Lot Number: JP2665B. 24. Item Number: TL1-10785055. UDI-DI: 10889981335106. Lot Number: JP2666B. 25. Item Number: TL1-10785060. UDI-DI: 10889981334949. Lot Number: JP2667B.
Devices named in this recall
25 devices in the FDA device registry whose identifier appears in the recall's code information.
- Virata TL1-10785060Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10775060Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10785055Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10775040Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10765055Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10755030Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10785045Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10775055Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10765050Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10775045Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10785035Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10775030Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10765045Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10765035Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10775035Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10755040Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10785040Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10765060Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10775050Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10785050Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10765030Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10755045Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10755035Seaspine Orthopedics Corporation · Thoracolumbosacral pedicle screw system1 recall0 reports
- Virata TL1-10755050Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
- Virata TL1-10765040Seaspine Orthopedics Corporation · APPLIANCE, FIXATION, SPINAL INTERLAMINAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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